Educational ProblemsNCT03577340
Development and Validation of Performance Metrics for Cardiac Device Implant Procedures
An observational study of Educational Problems, run by Liverpool Heart and Chest Hospital NHS Foundation Trust.
Trial summary
Cardiac Device implantation includes implantation of pacemakers, implantable defibrillators and Cardiac resynchronisation Therapy (CRT) devices. These are well-established treatments for selected with heart rhythm abnormalities and heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Educational Problems
- What is being tested?
- implant of cardiac device as per guidelines
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an observational and educational study only. Cardiac device implants routinely performed in clinical practice will be video-recorded. The procedures will be scheduled as per normal and the clinical pathway and management of the patient and the operator will remain unchanged.
Who may be able to join
- Patients eligible for a cardiac device implant as per current European Society of Cardiology guidelines.
Who cannot join
- Patient< 18 y of age. Patients unable to provide informed written consent for the study.
- -
About this study
Official title: Development and Validation of Performance Metrics for Cardiac Device
Cardiac Device implantation includes implantation of pacemakers, implantable defibrillators and Cardiac resynchronisation Therapy (CRT) devices. These are well-established treatments for selected with heart rhythm abnormalities and heart failure.
In the past, trainee doctors had the opportunity to perform many procedures and learn on the patient. This is no longer the case due to a change in training schedules and working times as well as patient safety mandates. Progression based training with the use of simulators has been proven to be effective in training and in order to use this methodology, the procedure needs to be well defined.
Read more
Despite its worldwide adoption, a standardized procedure has never been defined in detail and agreed upon and the cardiac device implant technique varies with the operator.
The purpose of the research is to establish the metrics (operational definitions) necessary to characterize a reference Cardiac Device implant procedure.
Read the detailed description
The purpose of the research is to establish the metrics (operational definitions) necessary to characterize a reference Cardiac Device implant procedure, to seek consensus from experienced device implanters on the appropriateness of the steps as well as errors identified, and to determine if such validated performance metrics are a valid assessment tool with the ability to discriminate between the performances of experienced and novice implanters.
These validated metrics will potentially serve as an educational and training tool to improve and quality assure Cardiac device implant training.
The steps involved in characterising a reference procedure are as follows:
- Define the implant procedure in quantifiable steps (already performed)
- Seek consensus and agreement by an independent panel on the steps (already done).
- Video record routinely performed device implants by experienced and novice physicians.
- Reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance.
- Conditions
- Educational Problems
- Being tested
- implant of cardiac device as per guidelines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant of cardiac device as per guidelinesOther
Observation of performance to validate matrix
| Study group | Role | What they receive |
|---|---|---|
| Novices | Novices: Trainee cardiologists implanting cardiac devices as per guidelines under supervision Receives: Other: implant of cardiac device as per guidelines | |
| Experts | Experts: Device implanting cardiologists implanting cardiac devices as per guidelines Receives: Other: implant of cardiac device as per guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the comparison of the intra-operative performance of novices versus experts
The primary analysis will compare the intra-operative performance of novices versus experts.
The three experienced cardiac device implanters will test the consented metrics by reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance. IRR will be considered to be acceptable if it is ≥ 0.8 The primary analysis will compare the intra-operative performance of novices versus experts.
The three experienced cardiac device implanters will test the consented metrics by reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance. IRR will be considered to be acceptable if it is ≥ 0.8
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Sep 2018 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Archana Rao, Liverpool Heart and Chest Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577340
- Sponsor's protocol ID
- 1189
- Status last verified
- Jul 2018
- First submitted
- 22 Jun 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Presentation at national and international meetings
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Performance Metrics for Cardiac Device
- ClinicalTrials.gov ID
- NCT03577340
- Acronym / sponsor ID
- 1189
- Conditions
- Educational Problems
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiac Device implantation includes implantation of pacemakers, implantable defibrillators and Cardiac resynchronisation Therapy (CRT) devices. These are well-established treatments for selected with heart rhythm abnormalities and heart failure.
In the past, trainee doctors had the opportunity to perform many procedures and learn on the patient. This is no longer the case due to a change in training schedules and working times as well as patient safety mandates. Progression based training with the use of simulators has been proven to be effective in training and in order to use this methodology, the procedure needs to be well defined.
Despite its worldwide adoption, a standardized procedure has never been defined in detail and agreed upon and the cardiac device implant technique varies with the operator.
The purpose of the research is to establish the metrics (operational definitions) necessary to characterize a reference Cardiac Device implant procedure.
Detailed description
The purpose of the research is to establish the metrics (operational definitions) necessary to characterize a reference Cardiac Device implant procedure, to seek consensus from experienced device implanters on the appropriateness of the steps as well as errors identified, and to determine if such validated performance metrics are a valid assessment tool with the ability to discriminate between the performances of experienced and novice implanters.
These validated metrics will potentially serve as an educational and training tool to improve and quality assure Cardiac device implant training.
The steps involved in characterising a reference procedure are as follows:
- Define the implant procedure in quantifiable steps (already performed)
- Seek consensus and agreement by an independent panel on the steps (already done).
- Video record routinely performed device implants by experienced and novice physicians.
- Reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novices | – | Other: implant of cardiac device as per guidelinesNovices: Trainee cardiologists implanting cardiac devices as per guidelines under supervision |
| Experts | – | Other: implant of cardiac device as per guidelinesExperts: Device implanting cardiologists implanting cardiac devices as per guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an observational and educational study only. Cardiac device implants routinely performed in clinical practice will be video-recorded. The procedures will be scheduled as per normal and the clinical pathway and management of the patient and the operator will remain unchanged.
Key inclusion criteria (1 listed)
- Patients eligible for a cardiac device implant as per current European Society of Cardiology guidelines.
Key exclusion criteria (2 listed)
- Patient< 18 y of age. Patients unable to provide informed written consent for the study.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implant of cardiac device as per guidelinesObservation of performance to validate matrix | Other | Experts, Novices |
Primary outcome
The primary outcome measure is the comparison of the intra-operative performance of novices versus experts
Time frame: 6 months
The primary analysis will compare the intra-operative performance of novices versus experts. The three experienced cardiac device implanters will test the consented metrics by reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance. IRR will be considered to be acceptable if it is ≥ 0.8 The primary analysis will compare the intra-operative performance of novices versus experts. The three experienced cardiac device implanters will test the consented metrics by reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance. IRR will be considered to be acceptable if it is ≥ 0.8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Individual participant dataSharing planned: Yes. Presentation at national and international meetings
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Educational Problems, run by Liverpool Heart and Chest Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the comparison of the intra-operative performance of novices versus experts (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.